Market Surveillance and Administrative Fines for Medical Devices in Turkey

1. Key takeaways

The Turkish Medical Device Regulation contains no fine schedule of its own. Instead, Madde 106 points sanctions towards the higher-ranking law on product safety. The administrative fines that companies actually face therefore come from Law No. 7223, in defined brackets, with a doubling rule for repeat violations within two years and a one-month payment window. This article maps the chain of authority and the figures.

• The Medical Device Regulation itself sets no fine table but points sanctions to the higher-ranking law: Madde 106 paragraph 1 provides that for violations of the regulation, the provisions of the Law on Product Safety and Technical Regulations, the Turkish Penal Code (No. 5237, dated 2004-09-26) and other relevant laws apply.
• The principal provision on administrative fines is Article 20 of Law No. 7223, with brackets as follows (amounts in Turkish lira, TL), each bracket carrying its own clearly defined range:
  • Paragraph 1 subparagraph (a): violations of provisions relating to product safety, 50,000—500,000;
  • Paragraph 1 subparagraphs (b) and (c), 20,000—200,000;
  • Paragraph 1 subparagraph (ç), 10,000—100,000;
  • Paragraph 1 subparagraph (d), 50,000—500,000;
  • Paragraph 1 subparagraph (e), 7,000—70,000;
  • Paragraph 2: obstructing inspection, 7,000—70,000.
• The aggravating element is set out in paragraph 8 of the same article: where the same act is repeated within two years, the fine is doubled for each repetition.
• The payment period is set out in paragraph 10: payment within 1 month from the date of notification.
• The definitions of market surveillance concepts and the inspection powers are found respectively in Madde 3 paragraph 1 of Law No. 7223 (the definitions of market surveillance and inspection, recall, and withdrawal from the market, in the Turkish terms piyasa gözetimi ve denetimi, geri çağırma and piyasadan çekme) and Madde 15 (inspection powers, with the possibility of delegation to other competent authorities).

2. Legal basis

Three instruments form the chain of authority: the product safety law that carries the fine brackets, the penal code referenced by the regulation, and the Medical Device Regulation itself with its pointing provision. Together they determine what a violation of the device regulation costs in administrative terms. The table below records their details.

3. Expert insights

Insight 1: the fines are not written in the Medical Device Regulation, a point that is often misunderstood. Many teams search the device regulation for penalty clauses and find nothing, because Madde 106 routes the entire question to Law No. 7223. When building a penalty ledger, the right artefact is a mapping table from provisions of the device regulation to the brackets of Article 20 of Law No. 7223. Without that mapping, exposure assessments understate the real risk, because the operative numbers never appear in the instrument the team is reading.

Insight 2: the doubling within two years is a compounding risk amplifier. The doubling rule in paragraph 8 uses a two-year window, and each repetition doubles the fine on top of the previous basis. For a company, this means that a violation which is not fully remediated and is repeated within two years accumulates costs quickly, well beyond the absolute value of a single fine. The rule effectively converts remediation quality into a financial variable: closing the root cause the first time is worth more than any fine negotiation.

Insight 3: obstructing an inspection carries its own fine. Paragraph 2 lists obstruction of inspection separately at 7,000—70,000. The bracket looks modest, but obstruction typically accompanies less favourable on-site handling and follow-up investigation by the authority. The standard conduct for receiving an inspection, including which documents are retrieved, who accompanies the inspectors and how records are kept, should therefore be written into employee training rather than left to the judgment of whoever happens to answer the door.

4. Practical recommendations

• Build a mapping table from violation scenarios to the brackets of Article 20 of Law No. 7223 and include it in compliance training.
• Set a two-year observation period for any violation that has occurred, and ensure that no similar act is repeated within that window.
• Prepare an inspection reception SOP that defines document retrieval, personnel accompaniment and record-keeping during on-site inspections.
• Track the payment deadline of 1 month from notification for any fine actually received, so that payment is never missed on a technicality.
• Record in the penalty ledger, for each mapped scenario, the responsible department and the remediation owner, so that the two-year doubling window can be managed with evidence rather than memory.

5. Verification checklist

• □ The chain of authority for fines has been confirmed: Madde 106 of the device regulation, then Article 20 of Law No. 7223.
• □ The fine brackets the company could touch have been checked (50,000—500,000 / 20,000—200,000 / 10,000—100,000 / 7,000—70,000).
• □ A two-year repeat-violation observation period and closed-loop remediation tracking have been set up.
• □ The payment period of 1 month from notification has been confirmed.
• □ An inspection reception SOP has been prepared and trained to named staff.

Regulatory information verified as of 29 October 2026. The brackets, doubling rule and payment period of Law No. 7223 cited in this article were checked against the original text of the Resmî Gazete; the pointing provision of Madde 106 of the device regulation was checked against the current text on the Turkish legislation information system (MevzuatNo 38657).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team manages adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com